Nottingham, N/A, United Kingdom
SUREPULSE MEDICAL LTD recalls
1 recall recorded since 2018, most recently on 20 January 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 20 January 2023
- Reason
- Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Distribution
- Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1359-2026, Z-1358-2026, Z-1357-2026, Z-1356-2026, Z-1360-2026
- Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
- Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
- Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
- Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
- Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.